From the diseases we face to the technologies we use to treat them, healthcare in the United States is changing rapidly.

Frank Magliochetti confirms: that just a few short decades ago, most people received care from their family doctor and paid for it through private insurance provided by an employer. Diagnostic tests were limited to x-rays and a few blood tests, and treatments involved first generation drug therapies and invasive surgical procedures. Patient records were kept in a dusty basement offsite, and the information they contained was accessed only to provide continuing care to that individual patient. Computerized medical records, advanced fMRI and CT scanning, and robot surgery common today was the stuff of science fiction just 20 years ago.

Tomorrow’s healthcare landscape will be decidedly different from the care provided today, and light-years away from the healthcare of our parent’s day. A number of various factors, such as demographics, legislation, and technology, affect nearly every level of healthcare and affect nearly every person working in healthcare. These factors will drive the major changes occurring in healthcare over the next two to three decades.

The diseases people
face will likely change as well. Diseases that were almost unheard of in
younger populations years ago, such as obesity, diabetes and heart disease,
will become major health issues across the generations.

The use of hospital services will
likely grow significantly in the next decade, largely because of the increase
in Medicare beneficiaries. The cost of hospital care will also rise; The George Washington University School of Business predicts
this cost will increase from 0.9 percent to 2.4 percent of the budget by 2025.

Care will likely
center on the patient’s experience, rather than on the needs of the
institutions providing that care. Patients will have detailed information, on
par with that collected by their doctor or hospital, about their own health and
about health in general. The patients of tomorrow will also enjoy greater
ownership of that data, and they will play a greater role in the decision-making
process when it comes to their own health, well-being and medical care.

The Healthcare of Tomorrow

Healthcare in 2040
is only 20 years away, but it will be vastly different from what we have today.
Two decades ago, we could not have envisioned the wearable devices that are
commonplace today; medical technology will take us places in the next two decade
that we cannot begin to imagine today. The next generation of sensors will
likely move from wearable devices to invisible, always-on sensors embedded in
devices surrounding us – or even embedded inside of us; medtech companies are
already investigating ways to incorporate these always-on biosensors and
software into devices that generate, gather and share health data.

By 2040,
independent streams of health data will merge to create a multifaceted, complex
and highly personalized picture of each individual’s well-being, for example.
Artificial intelligence (AI) will allow for wide scale analysis of vast amounts
of information and the creation of personalized insights into consumer health.
The availability of this data and personalized insights can enable precision
real-time interventions that allows patients and their caregivers to get ahead
of sickness early enough to avoid catastrophic disease. Armed with a lifetime
of highly detailed information about their own health and with a natural
penchant for mobility, consumers of 2040 will also probably demand that their
health information be portable.

Because of the
demand for mobility and information management, technology such as
interoperable data and AI will be major drivers of change, but only if the open
platforms necessary for mobility and AI are secure. Information technology (IT)
professionals will continually develop technologies that process threat data
more efficiently and more accurately predict criminal activity.

While nobody can
predict exactly what the healthcare landscape will look like in 2040 and
beyond, nearly everyone can agree that it will be vastly different from the
care we receive today.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

The Structure of the Healthcare Industry will Change Radically

The healthcare industry is changing at a blistering pace. Healthcare policies, technologies, insurance coverage, and the new focus on patient experience have triggered the evolution of healthcare into something yesterday’s providers would never recognize. And, chances are, the healthcare of tomorrow will look drastically different than the care provided today.

Change had come slowly to healthcare industry legislation in the nation’s early years. The first attempt at national health insurance came about in 1905, with the formation of the American Association for Labor Legislation; Speaker of the House Thaddeus Sweet vetoed the bill. The next major change in the healthcare industry didn’t come along until 1965 when, after 20 years of heated debate in Congress, President Lyndon B. Johnson initiated legislation introducing Medicare and Medicaid. The 2010 Patient Protection and Affordable Care Act was the last major healthcare legislation.

While changes to healthcare law and healthcare insurance had came slowly, the nation’s demographics and need for medical care is now changing rapidly. Furthermore, advances in research and medical technology have fueled an astonishing metamorphosis in healthcare.

Factors Contributing to the Changing Landscape of Healthcare

Perhaps the most notable change in healthcare is its explosive growth: healthcare became the largest employer in the United States in the third quarter of 2018, according to The Atlantic.

The nation’s aging population is a major driver of the healthcare job boom. By the year 2025, one-quarter of the workforce will be older than 55. By 2030, more than 170 million people in the United States will have at least one chronic health condition, according to the American Hospital Association (AHA). The rising population of older adults, and the increasing number of people with chronic illnesses, will require a growing pool of healthcare workers. In fact, the U.S. Bureau of Labor Statistics (BLS) expects jobs in the healthcare industry to account for a large share of new jobs created through 2026.

Other factors, including the health insurance market and healthcare regulation, will affect the structure of the healthcare industry. About half of the privately insured are covered under self-insured plans, which can vary dramatically.

The healthcare system is also moving towards a financial model based on value, rather than on volume. This shift will change the focus from treating diseases in hospitals to keeping patients healthy and out of the hospital.

Expect Monumental Changes in the Healthcare Industry

To handle these changes, the structure of the healthcare industry will undergo radical transformation in a number of areas, from insurance to the makeup of the board and the role of clinicians in leading renovations within an organization.

Provider organizations offering insurance products will likely experience substantial restructuring because they are essentially creating new businesses in a highly volatile market. In fact, several health systems have already introduced health plans in recent years, according to the Healthcare Financial Management Association.

Organizations without such products are restructuring, creating regionally focused, value-based care teams and enhancing consumer engagement. Moving towards a value-based system requires increased collaboration between health systems and health plans, the implementation of patient-centric technology, increased adoption of virtual care options, and a greater focus on public health. It also requires greater understanding of patient motivation and behavior, so many healthcare organizations will restructure to include patient experience departments.

Changes in organizational structures will manifest themselves in a number of ways. Evolution of an organization’s structure may include centralization and professionalization of the board to look more like boards in other industries, for example. This shift allows senior business leaders with niche expertise to guide healthcare organizations through insurance, risk management, IT, consumer engagement, investments and capital allocation.

Many healthcare organizations are putting physicians in leadership roles, asking their clinicians to lead clinical informatics, care model transformation, and population health management initiatives. In this way, the Chief Medical Officer (CMO) is evolving into the role of Chief Transformation Officer.

While it is nearly impossible to predict where the healthcare industry will be at the end of the 21st Century, it is safe to say that healthcare in the United States will undergo more changes in the next 80 years than it has in the entire history of the nation.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Frank Magliochetti declares that; Health information technology now plays an important role in patient care, payment and research, but it wasn’t always this way. Today’s health information technology represents an evolution in record keeping within the healthcare industry. In 1924, the American College of Surgeons adopted the Minimum Standard Document to ensure the recording of a complete case record that included identifying data, chief complaint, personal and family history, physical examinations, laboratory results and x-rays.

In the 20th Century, those records were written by hand and paper copies were generally stored on or offsite, unless required for a hospitalization, doctor visit or research. Sharing patient information with even one consultant or payer typically meant long hours at the copying machine to create thick envelopes filled with data that could take a substantial amount of time to sort; sharing only pertinent information with multiple parties was next to impossible.

Each of these events
paved the way to today’s already robust and rapidly growing information
technology business. HITECH seems to have worked – as of 2017, 86 percent of
office-based physicians had adopted an EHR and 96 percent of all non-federal,
acute care hospitals had a certified health IT department or person, according
to the Office of the National Coordinator for Health Information
Technology.

Today’s HIT Business

To meet the growing
demand on the clinical side, hundreds of healthcare IT software and service
companies have sprung up across the country. Healthcare IT Skills lists more than 350
such companies, including EHRs, consulting firms, medical device providers,
population health, revenue cycle management, analytics, and more.

Healthcare information
technology (HIT) merges electronic systems with healthcare to store, share and
analyze patient information. The advanced technology also integrates with
practice management software to improve office functions that lead to better
patient care. HIT now features patient portals that provides patients with
access to their medical history, allows them to make appointments, message
their practitioner, view bills and even pay bills online. HIT also includes
features to make practitioners’ lives easier, such as ePrescribing, remote
patient monitoring, and master patient indexes (MPIs) that connects patient
databases with more than one database, which allows different departments
within a facility to share all of the data simultaneously. MPIs reduce the need
for manual duplication of patient records for filling out claims and decrease errors
involving patient information, which can result in fewer patient claim denials.

As with any disruptive
technology, healthcare information technology has its drawbacks and its
critics. Some complain that EHRs have led to practitioners spending more time
sitting in front of a computer than talk with patients. Others bemoan the
cumbersome federal regulations involved. The benefits of HIT, however far
outweigh its downsides.

Advantages of today’s
health information technology include the ability to use big data and data
analytics to manage population health manage programs effectively, for example,
which is impossible with old-fashioned paper records. HIT can use data and
analytics to reduce the incidence of expensive and debilitating chronic health
conditions, use cognitive computing and analytics to perform precision medicine
(PM) tailored to each patient’s needs, and create a means by which academic
researchers to share data in hopes of developing new medical therapies and
drugs. Lastly, health information technology allows patients to obtain and use
their own health data, and to collaborate more fully in their own care with
doctors.

Tomorrow’s HIT
companies will use artificial intelligence (AI), virtual simulations, and other
emerging technologies to further enhance and improve healthcare. Technologies
will include digital insurance markets, price transparency tools, cloud storage
that will render costly and insecure data centers obsolete, self-serve mobile
applications that will eliminate forms and faxes, and centralized
clearinghouses that share information across organizations and state lines.
Many of these HIT applications will improve labor productivity and, given the
fact that wages account for 56 percent of all healthcare spending,
improvements in this area could generate significant economic gains.

Information technology will undoubtedly continue in its growth as an important and increasingly essential part of healthcare. The benefits of HIT will also continue to expand, as researchers, doctors, patients and healthcare companies integrate healthcare information technology into their everyday lives and standard business practices

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Will Precision Medicine Become Commonplace?

Precision medicine is a relatively new and powerful approach to medical care. Given its current growth rate and potential, precision medicine will likely be commonplace very soon.

Medicine is not always a one-size-fits-all solution – what works for one patient may not work at all for another. Individual differences in biology, environmental factors, and lifestyle may play a role in the risk of disease, affect symptoms, and even influence how well treatment works.

Treatments that shrink tumors or alleviate symptoms of arthritis in some patients, for example, are not always effective for other patients. Precision medicine aims to overcome the influences of biology, environment and lifestyle by matching the right treatments with the right patients.

Precision medicine
involves the use of extensive medical testing that identifies unique
differences in a patient’s condition, followed by the development of a
treatment plan specific to that patient. In other words, doctors will run tests
to identify unique characteristics that might make a patient more susceptible
or resistant to certain diseases or treatments, and then create personalized
treatment plans for each patient.

Precision medicine
allows researchers and prescribers to predict which treatments and prevention
strategies will work best to treat diseases in which groups of people. In
contrast, the one-size-fits-all approach uses treatments and disease strategies
designed for the average person.

Past, Present and Future of Precision Medicine

While the term
“precision medicine” is relatively new, the concept of providing
patient-specific treatment has been around for decades. For example, doctors
perform blood tests to match patients with the right type of blood; they have
been doing this since the early 1900s.

The advent of modern personalized medicine began about 20 years ago, when oncologists began using targeted therapy to treat HER-2 positive breast cancer. Precision medicine got a boost in 2015 with the introduction of the National Institutes of Health (NIH) Precision Medicine Initiative. NIH introduced the initiative in hopes of moving “the concept of precision medicine into clinical practice.” In other words, the initiative intends to make precision medicine commonplace.

The targeted,
personalized approach already has a significant effect on many areas of
medicine, including genomics that studies genes and their function, medical
devices, and laboratory testing. Patients already benefit from precision
medicine, especially patients with cancer. Doctors can use genetic testing to
determine if a patient is at high risk for developing certain kinds of cancer,
for example. When tests show that a person has a higher risk of cancer, a
doctor can suggest ways to lower that risk. Cancerous tumors also provide
genetic information that helps doctors develop more effective personalized
treatment plans.

The Precision Medicine Initiative has helped spur the commercial growth of precision medicine. The number of commercialized lab tests, known as predictive biomarker assays, is increasing dramatically. Predictive biomarker assays help doctors, pharmaceutical researchers and manufacturers predict the effectiveness of a treatment in any given patient group. These tests also help classify patients’ unique characteristics, which allow researchers and doctors to come up with the safest, most effective treatment for those specific patients.

Advancements in genome
sequencing, an increase in consumer-focused healthcare, and innovations in
healthcare information technology (IT) and connectivity have fueled explosive
growth in the precision medicine market. Market Watch reports the value of the global precision medicine market
at USD 47.43 billion in 2019, and projects the market will grow at a Compound
Annual Growth Rate (CAGR) of 12.3 percent to reach a net market size of USD
119.90 billion in 2025.

Precision medicine will also stimulate further research exploring the genetic, environmental, and lifestyle factors that influence the development of disease and response to treatment. This research will likely bring about innovations that make precision medicine commonplace in clinical medicine.

Frank Magliochetti News will be centered around reporting on trends, innovations, and news in the healthcare and bio/pharma industries.

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Earlier this year, Frank was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries.Media Crush

Even Vaccinated People Can Get the Measles

Measles are a serious infectious disease that can cause serious complications, such as ear infections, inflammation of the throat and lungs, pneumonia, swelling of the brain known as encephalitis, and pregnancy problems. Once very common, measles are now rare thanks to vaccinations, but people who have been vaccinated can still get the measles.

The measles vaccine became widely available in 1963. In the decade prior to the vaccine, measles infected 3 to 4 million people in the United States each year, according to the Centers for Disease Control and Prevention (CDC). Of the cases reported, 400 to 500 people died, 48,000 were hospitalized, and 1,000 suffered encephalitis from measles each year.

Widespread immunization drastically reduced measles rates right away, but the rate of measles began to creep up again in fully vaccinated communities. In 1989, health officials recommended receiving two doses, with the first at 12 to 15 months old and the second at 4 to 6 years old. One dose of the measles vaccine is about 93 percent effective at preventing measles, while two doses are about 97 percent effective. The immunity provided by the measles vaccination is long-term and probably lifelong.

The aggressive two-dose measles vaccination campaign eliminated measles from the U.S. in 2000. Now a measles outbreak is sweeping the nation and 2019 is shaping up to be one of the worst years for measles since its elimination nearly 20 years ago. This trend is worrisome for the very young, the very ill and other people who cannot receive a vaccination, as it puts them at risk of contracting measles. The increase of measles also increases the risk of infection among people who have received a measles vaccination but are still at risk of getting sick from the measles. Doctors refer to this group of people as “vaccine non-responders.”

About Measles Vaccines and Vaccine Non-responders

Immunization with the measles vaccine, known as the mumps-measles-rubella (MMR) vaccine, reduces the risk of infection with measles when exposed to the virus that causes the disease. Immunization with the MMR vaccine can also reduce the severity of symptoms if vaccinated individuals do get the measles.

Vaccinations work by “teaching” the immune system how to recognize and attach the measles virus. Vaccinations involve the introduction of live, attenuated measles virus. That means the vaccine contains a harmless version of the measles virus. The body responds to the presence of the vaccine by creating antibodies that will fight any measles virus they encounter in the future.

Some people have a strong response to immunizations with the measles vaccine, and develop a robust army of measles antibodies. These high-responders have a very low risk of contracting measles when exposed to the virus. Low-responders, whose bodies may have developed only a few antibodies to the measles virus, may contract measles but experience only mild to moderate symptoms.

Certain factors can influence a vaccine’s effectiveness. The viruses inside vaccines can die during the attenuation process to alter its effectiveness, for example. Administering vaccinations at the wrong time or incorrectly can also lower the effectiveness of the vaccine. Host-related factors, such as a person’s genetics, immune status, age, health, and even nutritional status can also affect how well a vaccine works.

While vaccinations may not provide 100 percent protection against the measles, it is still important that everyone who can receive vaccinations have the MMR. Widespread vaccination provides “herd immunity” that prevents serious viruses like measles from spread to those who either cannot receive the vaccine or who are low- or non-responders.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

CRISPR Has the Potential to Snip Out Sickle Cell Disease

Sickle cell disease affects about 100,000 people in the United States, according to the Centers for Disease Control and Prevention (CDC), and affects millions of people across the globe. A new technology, known as CRISPR, may change all that.

CRISPR is short for “clustered regularly interspaced short palindromic repeats.” It is a group of technologies capable of editing the genes in people with inherited conditions, such as sickle cell disease.

Sickle cell disease is an inherited disorder that affects red blood cells, which transport oxygen to the rest of the body. Specifically, sickle cell disorders affect hemoglobin (Hgb), which is the protein in red blood cells responsible for transporting oxygen. A mutation in a single DNA letter (S) causes the sickle cell trait to be passed from one generation to the next. People with sickle cell disorders inherit an abnormal version of hemoglobin, known as Hgb S, which distorts the shape of the red blood cells.

Red blood cells normally have a round donut shape that allows them to carry an ample supply of oxygen, and to flow through tiny blood vessels smoothly. People with sickle cell inherit a trait that, during a sickle cell crisis, causes the normally round blood cells to resemble the C-shaped farm tool known as a sickle. The sickle cells become hard and sticky, so they clump together instead of flowing freely.

The cells are fragile and prone to rupturing, which can lead to anemia. The deformed cells also die early, which causes a constant shortage of red blood cells. The abnormal shape also means the cells can block blood vessels and damage tissue. This can cause pain, infections, a lung problem known as acute chest syndrome, stroke and other serious health issues during a sickle cell crisis and afterwards.

Current treatments involve blood transfusions, the drug hydroxyurea and bone marrow transplants. Each of these comes with risks and complications.

Enter CRISPR

CRISPR is a group of gene editing technologies that allow scientists to change an organisms DNA by adding, removing or altering specific locations within the gene. Researchers created CRISPR by adapting a naturally occurring gene editing system in bacteria, which captures little snippets of an invading virus’s genes. If the virus ever attacks again, the bacteria use the snippets to create and insert a new DNA sequence into the virus, which effectively changes the virus.

The technology works the same in the lab, except to produce positive results. Scientists first remove the snippet of the “bad” gene that causes sickle cell, using CRISPR to cut the sickle cell gene (S) from a precise location in DNA, and replaces it with healthy genes. Scientists then attach healthy hemoglobin genes to a harmless virus, and then put the virus and the corrected genes it carries back in the patient’s body.

Researchers from the National Institutes of Health performed a clinical trial in which they used CRISPR to edit the genes of nine people with sickle cell disease. The lead researcher, John Tisdale, spoke about their progress and said that all of the people who had received the gene therapy had good hemoglobin levels and that none of the participants had experienced sickle cell crises.

More research is necessary before gene editing becomes a common course of treatment, but CRISPR may someday help all people overcome sickle cell disease and its complications.

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Pharmacogenomic Testing: Could it Reduce Health Care Cost?

A relatively new type of drug testing could reduce health care costs. This type of testing is known as pharmacogenomic testing. It looks at how the genes a person inherits affects how medications works in his or her body.

Many things can affect how drugs work in the body. Someone’s size can be a factor, for example, as a large person needs more of a drug than does a small person. A person’s diet can also affect how well his or her body absorbs and uses medications.

Genes can also affect how a person’s body responds to drugs. Differences in genetic makeup between people influences what their bodies do to a drug and what a drug does to their bodies. A person’s genetic makeup may cause slow metabolism of medications, for example, and this can cause the drugs to accumulate to toxic levels in the body. Other people metabolize drugs so quickly that drug levels never get high enough to provide a therapeutic effect.

About Pharmacogenomics

In pharmacogenomics, scientists study the genetic differences that affect the response to drugs. The word “pharmacogenomics” is a combination of the word’s pharmacology and genomics; pharmacology is the study of the uses and effects of medications, while genomics is the study of genes and their functions. The aim of pharmacogenomics is to develop safe, effective medications and doses tailored to an individual’s genetic makeup.

Pharmacogenomic testing helps researchers get a better understanding of the relationship between genetics and drug response. This understanding ultimately leads to treatments that work better and cost less.

Most of the medications currently available are “one size fits all,” but these drugs do not work the same way for everybody due to genetic differences. These inherited differences can make it difficult to predict who will benefit from a drug, who will not respond at all, and who will suffer negative side effects. Incorrect predictions can lead to prescribing drugs that do not work, work poorly, or worst of all, cause adverse side effects.

The Food and Drug Administration (FDA) tracks adverse drug reactions and issues “black box warnings” for medications that have the potential for severe side effects associated with genetic predispositions and other causes. These warnings, which apply to more than 200 drugs, help doctors choose the right medications. In some cases, the black box warnings contain genomic information that alerts doctors to the potential risk of adverse reactions and provides dosing instructions according to pharmacogenomic testing results.

Pharmacogenomic testing can reduce health care costs by helping doctors prescribe medications that those patients who are genetically predisposed to benefiting from the drug. This testing can also reduces the risk of adverse events in patients with a certain genetic predisposition.

Negative side effects, also known as adverse drug reactions or adverse drug events, are a significant cause of hospitalizations and death. Adverse drug reactions lead to approximately 1.3 million emergency department (ED) visits and 350,000 hospitalizations every year, according to the Centers for Disease Control and Prevention (CDC). The FDA says that adverse drug events may be the fourth leading cause of death in the United States, causing more than 106,000 deaths annually.

Adverse drug reactions are dangerous, but they are also costly. Adverse drug events cost the nation about $3.5 billion in excess medical costs every year. These drug reactions affect about 2 million hospitalizations each year and prolong these hospital stays by 1.7 to 4.6 days, which significantly adds to the cost of hospital care. Outside the hospital, adverse drug reactions result in more than 3.5 million visits to doctor offices, approximately a million emergency department visits and around 125,000 admissions to the hospital. More than 40 percent of the costs related to adverse drug reactions occurring outside the hospital may be preventable.

About Pharmacogenomic Testing and its Benefits

Researchers are using information from the Human Genome Project to investigate how genetics affects the body’s response to medications. The results help researchers to predict whether a drug will work effectively for a particular person, and to help prevent adverse drug events.

The test requires a small blood or saliva sample. Laboratory technicians perform tests that look for changes or variants in one or more genes, which can affect your body’s response to certain medications.

Pharmacogenomic testing evaluates the genetic factors that affect how your body metabolizes medications. The information gained from the test helps your doctor determine if a particular medication is right for you, calculate the correct dosage to adjust for your metabolism, and to help predict whether you could experience serious side effects from the drug. It can also save money.

Medical and finance expert Frank Magliochetti explains;

Healthcare spending in the United States reached $3.5 trillion in 2017, rising by 3.9% year-on-year and accounting for 17.9% of gross domestic product (GDP), according to data from the Centers for Medicare and Medicaid Services (CMS). Independent federal actuaries estimate that the amount climbed to $3.65 trillion in 2018, and the Organization for Economic Co-Operation and Development (OECD) ranks the United States as the country with the highest health expenditure per capita. According to CMS projections, US spending will continue to grow at an average rate of 5.5% annually through 2026, when it is expected to reach $5.7 trillion and account for 19.7% of GDP. These massive and steadily rising costs are a source of concern for the government, which is constantly exploring means of reining in healthcare expenses, including through preventive measures and investment in research projects. Among the most promising new developments is pharmacogenomic testing, which involves studying the impact of people’s genetic makeup on their response to drugs so that effective and efficient treatment regimens can be devised

Frank Magliochetti owes his professional success to his expertise in two areas: medicine and finance. After obtaining a BS in pharmacy from Northeastern University, he stayed on to enroll in the Masters of Toxicology program. He later specialized in corporate finance, receiving an MBA from The Sawyer School of Business at Suffolk University. His educational background includes completion of the Advanced Management Program at Harvard Business School and the General Management Program at Stanford Business School. Frank Magliochetti has held senior positions at Baxter International, Kontron Instruments, Haemonetics Corporation, and Sandoz. Since 2000, he has been a managing partner at Parcae Capital, where he focuses on financial restructuring and interim management services for companies in the healthcare, media, and alternative energy industries. Earlier this year, he was appointed chairman of the board at Grace Health Technology, a company providing an enterprise solution for the laboratory environment.

Genetic Cancer Screening Benefits for You and for Your Family

Genetic cancer screening can be one of the greatest gifts you can give to yourself and to your family.

Cancer seems to “run in families.” Sometimes this is because families share an environment or lifestyle, such as tobacco use, known to increase the risk of cancer. At other times, mutations in the genes passed from one generation to the next increases a person’s cancer risk. Researchers think that genetic mutations play a role in approximately 5 to 10 percent of all cancers, according to the National Cancer Institute.

Researchers have not identified genetic causes for every type of cancer but they have discovered several gene changes, or mutations, which can pass from a parent to child. These mutations can increase a person’s risk of developing certain types of cancer. Scientists refer to these genetic changes as “hereditary cancer syndromes.”

Types of Hereditary Cancer Syndromes

Hereditary Breast & Ovarian Cancer Syndrome (HBOC)

Medical scientists think that about 5 to 10 percent of breast cancer cases are hereditary, according to the American Cancer Society. Hereditary breast and ovarian cancer syndrome (HBOC) is the most common type of inherited breast cancer. HBOC is the result of mutations in two genes, BRCA1 and BRCA2. A woman who inherits mutations of these genes has a higher risk of developing breast and ovarian cancer during her lifetime than does a woman who does not carry that mutation.

Mutations in BRCA genes can also affect men. A man with an inherited BRCA gene mutation has a higher change of developing breast and prostate cancer at some point in his life. Furthermore, some families with a mutation in the BRCA gene have a higher risk of developing pancreatic cancer, colon cancer and the skin cancer known as melanoma. Mutations in BRCA genes can greatly increase the risk of lung cancer – smokers have about a 13 percent lifetime chance of lung cancer, according to Cancer Discovery, but that risk nearly doubles to 25 percent for smokers with particular BRCA2 mutation.

Mutations in other genes can increase someone’s risk of developing cancer. Mutations in the EGFR, KRAS, and ALK genes can increase the risk for lung cancer. Changes in the MSH2, MLH1, MSH6, PMS2 or EPCAM genes increases the risk of cancers included in Lynch syndrome, such as colorectal cancer and cancer of the endometrium, ovaries, pancreas, small intestine, liver, stomach, brain and breast. Mutations in the TP53 gene can increase the risk of cancers in Li-Fraumeni syndrome, such as bone cancer, leukemia, brain tumors, cancer of the adrenal glands, breast cancer, and other cancers.

For many people, cancer develops as the result of inherited genetic mutations coupled with the effects of lifestyle choices. This means someone with a mutation of the EGFR, KRAS or ALK gene who smokes has a higher risk of developing lung cancer than does someone with the gene mutations that does not smoke.

Benefits of Genetic Testing for You and Your Family

Genetic testing provides several advantages, to both you and your family. Finding out the results of your genetic testing brings a sense of relief from uncertainty, for example. Genetic screening can also provide in-depth knowledge about your personal risk of cancer and provide the information you need to make informed lifestyle and medical decisions.

Perhaps the best benefit of all is genetic testing gives you an opportunity to help educate other family members about their risk for cancer so that they can make positive lifestyle and medical choices too.

If you have mutations of BRCA 1 and BRCA 2 genes, there is a probability that your family members could also have the genetic mutation. Knowing that you have the gene gives you an opportunity to be proactive and to take preventive action, which can change the trajectory of the outcome. For greatest ease of mind, every member of the family tree should undergo CGX testing.

A team of researchers in Spain reports the development of a new three-dimensional (3D) printer capable of printing human skin suitable for transplant into patients. The printed skin is also suitable for testing drugs and cosmetics.

The team included several groups of researchers, including a group from the Universidad Carlos III de Madrid (UC3M) in Spain. The researchers describe their breakthrough in the scientific journal, Biofabrication.

3D Printing and Skin Production

3D printing has been around since the 1980s, when Charles (Chuck) Hull introduced the first stereolithography apparatus (SLA), but the 3D printing industry is now experience rapid growth with applications in many fields. In medicine, 3D printing holds great promise in someday giving clinicians the ability to produce personalized, complex human tissues and organs on demand. One woman has already received a 3D printed ear from one company, for example, while another company provides 3D printed implants that the recipient’s body converts to bone.

Three-dimensional printing of human body parts is challenging in a number of ways. Replicating the complexity of anatomical structures is difficult. Ensuring the printed tissue survive transplantation in a living body is another problem.

The scientists in Spain have already engineered plasma-based, two-layered skin used successfully in the treatment of burns and other wounds in a large number of patients. The primary drawback to this method is that it takes 3 weeks to produce enough skin to cover an extensive burn or large wound. Another disadvantage is that the scientists must perform much of the process manually.

3D printing is similar to a desktop computer printer except that the nozzle on the 3D printer exudes biological components rather than ink. These biological components, or bio-inks, are essential to successful 3D printing of human organs and tissues.

To aid in the process, a computer controls the nozzles and flow of biological components so that the nozzles deposit the bio-inks on precise locations on the print bed.

Prints large area of skin in 35 minutes

The authors of the study describe how their 3D printing method generated a 100 x 100 centimeter area of skin in just under 35 minutes.

Like the scientists’ existing plasma-based manual method of producing skin, the 3D printing technology generates two layers of skin – the epidermis and the dermis. The printer starts by producing the epidermis, including the protective outermost layer of keratinized cells, known as the stratum corneum. Next, it prints the thicker, deeper dermis, complete with collagen-producing fibroblasts.

The new 3D printing method is faster, but still complex. One of the authors of the report, Juan Francisco del Cañizo of the Hospital General Universitario Gregorio Marañón and Universidad Complutense de Madrid, notes:

“Knowing how to mix the biological components, in what conditions to work with them so that the cells don’t deteriorate, and how to correctly deposit the product is critical to the system.”

The research team tested the printed skin in test tubes and in immunodeficient mice. Transplantation of the printed skin into the mice helped the scientists test the long-term effects in a living animal. In both tests, the 3D printed skin was very similar to human skin and indistinguishable from the manually produced bi-layered skin from plasma.

There are two main potential uses for this 3D skin – to produce skin for research and laboratory testing of drugs and cosmetics, and to produce person-specific skin from the patient’s own cells to treat burns and other wounds. The research team is also investigating ways to use the technology to print other human tissues.

North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry. Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

Telemedicine for Assessing Levels of Consciousness in Comatose Patients: How Does it Compare to Bedside Assessment?

Effective care for comatose patients in intensive care units (ICUs) depends on proper intervention based on reliable assessment. Researchers recently conducted a study at Mayo Clinic Hospital in Arizona to compare the effectiveness of using telemedicine to assess levels of consciousness in comatose patients with standard bedside assessment.

Proper intervention relies on the ability to recognize changes in a comatose patient’s clinical status quickly. This had usually meant that, in order to complete an assessment, the practitioner needed to be in the same room. Advanced medical technology is changing all that and robotic medicine now allows clinicians to assess patients from across the hospital or from across the world.

Telemedicine has been around since the 1960s, when NASA built telemedicine technology into astronauts’ suits. Prior to this technology, astronauts had to rely on crewmates for an accurate diagnosis. Monitors in the suits sent biometric information about the wearer back to earth for assessment.

Computers have revolutionized telemedicine and the internet helps doctors assess patients living in remote places. This is especially helpful for patients living in underserved areas.

Despite major advances, many still worry about the effectiveness in using this technology for the most critically ill patients. A new study published in Telemedicine and e-Health should help to dispel this fear, with researchers showing that robotic telemedicine can be used successfully to complete assessments in comatose ICU patients.

Testing the Reliability of Telemedicine in the Assessment of Levels of Consciousness

Researchers enrolled 100 patients from Mayo Clinic Hospital in Arizona into the study, which occurred over a 15-month timeframe. Mean age of patient participants was 70.8 years. On average, each examination took just over 5 minutes.

Sixteen medical doctors also participated by using two scoring systems, the Glasgow Coma Scale (GCS) and the Full Outline of UnResponsiveness (FOUR) score, to assess patients’ levels of consciousness. The researchers randomly assigned two practitioners to each patient; one doctor used real-time audio and a visual robotic telemedicine system to perform the assessment and the other clinician conducted an assessment at the patient’s bedside. Each used GCS and FOUR scales.

The researchers used paired t-test and Pearson correlation coefficient (PCC) to compare the GCS and FOUR scores between bedside and remote physician.

Differences in GCS and FOUR scores between remote and beside assessment were small. The mean Glasgow Coma Scale score at bedside was 7.5 while the mean GCS score for the remote examination was 7.23. Scores were comparable in the FOUR total scores too, with a mean bedside score of 9.63 and a mean remote score of 9.21.

The researchers also asked the clinicians about their overall satisfaction and ease of use. Ninety-five percent of remote providers rated GCS and 89% rated FOUR score as good (4/5).

Conclusions

The study is the first to evaluate the effectiveness of telemedicine in assessing patients with depressed levels of consciousness. The results suggest that doctors can reliably assess levels of consciousness in comatose patients using existing robotic telemedicine technology. Healthcare providers could adopt telemedicine to help evaluate critically ill patients in neurologically underserved areas.

“This is good news in many ways,” states lead author of the study, Amelia Adcock, M.D, in a press release issued by Mayo Clinic. “We use telemedicine frequently when evaluating acute stroke patients. This study suggests yet another way telemedicine can enhance patient care. There is a shortage of intensive care unit providers and facilities with round-the-clock patient coverage. Telemedicine can provide a way to ameliorate this shortage and improve early evaluation of critically ill patients.”

North Andover, Massachusetts

This column of posts is directed at the Healthcare Industry. Frank plans to release new sites dedicated to the industry. Frank currently assists companies who are building, restructuring, transforming and resurrecting there business’s. An example of his client base are, Xenetic Biosciences , IPC Medical Corp, Just Fellowship Corp, Environmental Services Inc., Parsons Post House LLC, ClickStream Corporation as well as having a business talk radio show; The Business Architect on the URBN network.

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